Efficacy and influence of neoadjuvant epirubicin/vinorelbine chemotherapy (EN) on molecular markers in inflammatory breast cancer (IBC) and preliminary results of a randomized study testing as adjuvant chemotherapy the same EN-combination versus docetaxel (TXT).

886 Background: IBC is the most aggressive form of breast cancer. The introduction of chemotherapy(CT) in multimodality approach of IBC resulted in improved survival, with about 30% pts alive and progression free at 10 yrs (Cancer Chemother. Pharmacol. 40:321,1997). The aims of the study were: a) to evaluate the efficacy and safety of primary EN-CT, b) to determine the predictive value and changes of molecular markers (ER, PR, Ki67 and HER2 status), and c) to evaluate a better CT schedule and sequence (primary and adjuvant).,From 2002 to 2004, 37 pts with IBC entered the study. Tumour specimens were obtained before CT by biopsy and surgery after, to evaluate the bio-markers. Median age 53 yrs. The characteristics of the 32 evaluable pts are: premenopausal 40%, histological G3 80%, ER negative 43%, Ki67 ≥25% 83% and HER2+ 64%. The treatment consisted of the following sequence: EN (E 120 mg/m d 1 plus N 25 mg/m d 1 & 8) x 4 cycles ⋄ Surgery or RT ⋄ randomization therapy between EN x 4 cycles or TXT (100 mg/m) x 4 cycles, both regimens were recycled every 3 wks. After adjuvant therapy all patients received RT and endocrine-therapy in ER/PgR+ tumors.,The clinical responses to induction CT in eval. pts, were: 4 cCR, 23 cPR 1 SD and 4 PD. After induction CT, 27/32 pts underwent to loco-regional therapy (26 radical mastectomy and 1 loco-regional RT). Pathologic responses were: 3 pCR and 23 pPR. After the loco-regional therapy the pts were randomly assigned between EN x 4 cycles and TXT x 4 cycles. At present 26 pts completed the entire treatment plan: 13 pts in each arm. At median 14 mos of follow-up, we observed 2 relapses and 1 death in TXT arm, and 2 relapse and 1 death in EN arm. Both sequential-CTs were manageable, feasible and well tolerated. Disease free survival and overall survival are too early to analyze.,The preliminary data suggest that the sequential use of two non-cross resistance CT schedules are well tolerated, active and feasible. A longer follow-up is needed to establish the exact role of these drugs in the therapy of IBC. The study is ongoing. No significant financial relationships to disclose.